Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02386605 · ClinicalTrials.gov registry record · NA
Motivational Negative Symptoms in Schizophrenia: Intervention and Biomarkers
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 99
- Enrollment target
NCT02386605: Completed NA study, sponsored by VA Office of Research and Development.
NCT02386605 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 99 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02386605, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 99 participants
- Enrollment target
Study Summary
Negative symptoms significantly interfere with daily functioning among individuals with schizophrenia. They are strongly related to functional impairments \[1\] and contribute to the poor community outcomes of Veterans with schizophrenia. Motivational negative symptoms interfere with obtaining and maintaining employment \[2\], forming social relationships\[3\] and living independently \[4\]. Developing treatments to effectively reduce negative symptoms is important to achieve improvements in daily functioning. Recent empirical studies report that psychosocial interventions for negative symptoms can have a moderate to large effect size on community functioning and negative symptom severity. However, the treatments that have been utilized so far are either cognitive-behavioral therapy interventions that require over a year of weekly individual sessions and thus are very resource- and time-intensive, or they are skills-training groups that do not address any of the cognitive and motivational aspects of negative symptoms. Although group treatments are increasingly hailed as the gold standard for schizophrenia, there is currently no group intervention explicitly for motivational negative symptoms and functional deficits. Furthermore, treatment development and clinical trials are increasingly reliant on neurophysiological measures of clinical severity and treatment response and so far there are not identified negative symptom biomarkers. The current CDA proposal will test a group-based treatment based on established motivational enhancement (MI) techniques, augmented with cognitive-behavioral approaches, compared to an active control group treatment, for improving motivational negative symptoms in Veterans with schizophrenia. I will assess the efficacy of MI with measures from two outcome domains: 1) negative symptoms (clinical ratings) and 2) functional outcomes (real-world improvements in social, instrumental, and independent living). I will assess the relationship bet
Interventions
- BEHAVIORAL Motivational Interviewing and Cognitive Behavioral Therapy
- BEHAVIORAL Relaxation Skills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2016-03-28 |
| Est. Completion | 2020-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02386605
The ClinicalTrials.gov registry entry for NCT02386605 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Motivational Interviewing and Cognitive Behavioral Therapy is the first listed.
NCT02386605 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02386605 about?
NCT02386605 is a clinical study titled "Motivational Negative Symptoms in Schizophrenia: Intervention and Biomarkers". Negative symptoms significantly interfere with daily functioning among individuals with schizophrenia. They are strongly related to functional impairments \[1\] and contribute to the poor community outcomes of Veterans with schizophrenia. Motivational negative symptoms interfere with obtaining and m...
What is the current status of trial NCT02386605?
This trial is currently completed. It is a NA study. The enrollment target is 99 participants. The study started on 2016-03-28. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT02386605?
The interventions under investigation include: Motivational Interviewing and Cognitive Behavioral Therapy (BEHAVIORAL), Relaxation Skills (BEHAVIORAL).
Who is sponsoring clinical trial NCT02386605?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.